QA 6050 00008 Quality Improvement
QA 6050 00008 Quality Improvement
QA 6050 00008 Quality Improvement
Quality Improvement
Revision History
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Quality Improvement Revision: 01R
Table of Contents
1 Objective 4
2 Scope 4
3 Input to Procedure 4
4 Output of Procedure 4
5 General 4
6.1 General 5
6.2 Process 5
7.1 Process 7
7.2 Observation 8
9 Management Review 10
9.1 General 10
9.2 Responsibilities 10
11 Abbreviations 12
12 Definitions 12
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1 Objective
To document the various processes that collectively contribute to Quality Improvement within the Project Design
Office, and in particular to the Quality Management System (QMS) itself.
2 Scope
This procedure is applicable to all aspects of the Project Design Office organisation.
3 Input to Procedure
Input From Activity name / Document Number
ISO 9001 Quality Management Systems - Requirements
4 Output of Procedure
Output To Activity / Document Number
Management Review Report.
QMS Action Tracker
5 General
This document satisfies the requirements contained in Section 8 and 5.6 of ISO 9001 regarding “Measurement,
analysis and improvement” and “Management Review”. It addresses requirements for:
Control of non-conformance, including non-conforming product;
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6.1 General
A Non-Conformance is where there has been a non-fulfilment of a requirement and Corrective Action is the action
taken to eliminate the cause of a Non-Conformance in order to prevent recurrence.
This section defines the method for processing non-conformances within the Design Office organisation. It covers the
full lifecycle from initiation to close out, and also addresses the necessary action taken to ensure recurrence is
prevented. The process ensures that all non-conformances are formally documented, and that all the necessary,
appropriate actions are identified and tracked to completion.
In addition, key information will be distributed to relevant personnel to share learning and increase overall knowledge.
This information can also be used to identify opportunities for improvement, and will form part of the Management
Review (see Section 9).
6.2 Process
A Non-Conformity Report (NCR) can be raised by any member of the organisation, and all personnel are encouraged
to identify non-conformity and report it, as an aid to improving the quality of service provided. Non-Conformity may
result for a variety of reasons, including failure to meet specified requirements, where significant cost or schedule
impact is foreseen, where there are concerns with procedural understanding, due to failure of communications,
general quality deficiencies, or management system breakdown.
The originator should discuss the discrepancy with the appropriate Technical (or other) Authority, their own Line
Manager, the QA Engineer, or with representatives of the affected organisation. Once agreed, the originator will raise
the NCR. The Quality focal point will assist in completion of the NCR, will register it in the QMS Action Tracker (see
Section10) and will coordinate associated activities including root cause analysis.
The NCR will generally identify the party responsible for implementation of action(s) to correct the discrepancy. The
action party will confirm acceptance of the action and agree an appropriate and realistic target date for completion.
If the NCR involves a supplier, the originator shall discuss the potential NCR with the parties responsible for Supplier
Management within the Project Team (e.g. Contract Holders), who will act as liaison point with the supplier.
Discussions with the supplier will recognize the preference for the supplier to raise the NCR within their own system.
The NCR form is provided at Appendix 1. An electronic version shall be used for generating NCR’s, which shall be
issued with a unique, sequential Non-Conformance number, and shall include all relevant information to enable a full
understanding of the requirements that have not been met.
Where applicable, non-conforming product should be identified in a suitable manner and be quarantined or segregated
to prevent inadvertent use. Only following satisfactory disposition, to use or rework the product shall it be removed
from quarantine. During any rework the product shall remain identified as non-conforming until such time that it
passes a satisfactory inspection. Non-Conformity may be resolved in a number of ways, including rework, accept
with / without repair, use for an alternative product or application, scrap, return to the supplier, or amend the system or
procedures. The disposition method used shall be noted in the Corrective Action part of the form.
The originator and / or the QA Engineer shall establish that the root cause(s) of the issue and verify that corrective
action has been completed successfully. Typically by audit, change to the management procedure, expert review of
documentation or engineering calculations, re-inspection, witnessing of repair procedures, or re-testing software
product.
Following completion, the NCR shall be signed-off by the originator and any other relevant parties to denote that close
out is accepted. The signed NCR shall be provided to the Quality focal point for update of the QMS Action Tracker.
The QA Team will use the QMS Action Tracker to generate reports covering trends and progress in individual areas
for input and discussion at Management Review meetings.
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6.3.1 High
The Finding significantly impacts upon HSE, Quality, Cost, Schedule and / or Corporate objectives i.e. there is a
complete breakdown of a defined requirement. Typically, a HIGH finding concludes that there are no or totally non-
effective processes and controls in place to manage the key activities. A HIGH finding requires the implementation of
appropriate action at the earliest opportunity appropriate to the risk.
6.3.2 Medium
The Finding may have a significant impact upon HSE, Quality, Cost, Schedule and / or Corporate objectives i.e. there
is a partial breakdown of a defined requirement. Typically, a MEDIUM finding concludes that the processes and
controls are only partially effective and / or that additional processes and controls may be needed in the near future to
manage key activities. A MEDIUM finding requires the implementation of appropriate action at the earliest opportunity
appropriate to the risk.
6.3.3 Low
The Finding is likely to have an insignificant impact upon HSE, Quality, Cost, Schedule and / or Corporate objectives
i.e. there is a minor breakdown of a defined requirement. Typically, a LOW finding concludes that the processes and
controls are mainly effective and / or that additional processes and controls may be needed in the near future to
manage key activities. A LOW finding requires the implementation of appropriate action appropriate to the risk.
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Preventive Action is for those cases where requirements are conformed to, however a potential non-conformance has
been identified and action must be taken in order to prevent the occurrence.
7.1 Process
This section provides a consistent process for the reporting of all improvement opportunities, providing a mechanism
for input to the continuous improvement process.
This procedure describes how action designed to eliminate potential causes of non-conformity is identified and
implemented. Preventive action can be demonstrated from a number of sources such as weekly project meetings, as
well as information gathered from the non-conformity / corrective action system, lessons learned, improvement
suggestions, and other sources, as applicable.
Quality improvements may be identified as a result of scheduled activities e.g. audits, reviews, inspections, self-
assessments, etc. or may arise during the course of normal working activities e.g. Project Meetings.
Improvement / Preventive Action may be identified by any member of the Project as the result of review or analysis of
the output from:
Audits
Management Reviews
Quality Management System Reviews
Project Meetings
Non-Conformity / Corrective Actions
Incident / Accident investigations
Improvement recommendations
The standard form included at Appendix 2 shall be used to detail an Improvement Proposal.
The following documents will be reviewed and analysed by the QA Team to identify any improvement potential from
both positive and negative findings.
Audit reports
Non-Conformity / Corrective Action Forms
Quality System / Management Review Minutes
Concession Request analyses
Improvement suggestions
This review is designed to verify the effectiveness of the various procedures, which form part of this process, identify
best practice for incorporation into the QMS, and determine where effective action can be taken to prevent
nonconformities. The Quality Management Team Discipline Head conducts the initial review, with relevant Team
Leaders from other functions involved as the requirement for action is identified and agreed.
The findings of the review will be recorded on an Improvement Proposal /Preventive Action form. The purpose of this
is to document agreed actions and demonstrate the linkage between the starting point (e.g. the non-conformity /
improvement suggestion) and the improvement action.
The QA Discipline Head will monitor the progress of the Improvement Proposal and close it out on completion of the
required action. The progress of all Improvement Proposals will be an input to the Management System Review.
7.2 Observation
Observations are for those cases where requirements are conformed to, however it is felt prudent that a statement of
fact, opinion or reflection is captured. An observation can be used to highlight a practice worth replicating, where there
is a finding which falls out-with the ToR/ Scope of an audit, or for recognising a noteworthy effort. An observation can
be positive or negative. An observation does not require to be actioned but is captured in the Action Tracker.
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Customer feedback data shall be acquired for subsequent review, action and trend analysis in order to measure
performance against a number of criteria.
7.3.1 Process
Customer feedback may be received in several ways including:
E-mails / phone calls from customer to Design Office contacts;
Customer completing and returning Feedback Questionnaire;
Outputs from Lessons Learned sessions on completion of work.
In order to capture ad hoc customer feedback, all recipients of feedback should forward the data to Design Office
Quality Team. Formal feedback is obtained through use of the Customer Feedback Questionnaires (Appendix 4).
This should be issued by the Project Design Lead at the end of the project scope of work.
On receipt of customer feedback data, the Quality Team will update the Customer Feedback Register, which will be
distributed on a regular basis, and will provide input to the QA Team Monthly Report presented to the Design Office
Leadership Team
On notification of receipt of customer feedback, the Project Design Leader will arrange for acknowledgement to be
issued to the customer and initial screening to determine the nature of feedback and if immediate action is required.
Following registration, acknowledgement and initial screening, each piece of customer feedback will be reviewed to
determine if any corrective action / preventive action is required in relation to the QMS.
The QA Team will co-ordinate the identification and tracking of required actions and action parties utilising the QMS
Action Tracker; they will also facilitate the analysis of customer feedback data to identify trends and recommended
QMS improvement actions to the Leadership Team. Any recommendations and actions will be recorded and
expedited to completion using the QMS Action Tracker.
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8 Management Review
8.1 General
A Management Review is carried out to ensure the continuing suitability, adequacy and effectiveness of the
Management System, and to take action, where required.
Information from various sources is used by the QA Discipline Head to coordinate the Management Review activities
and documented records which are required to comply with the requirements of ISO 9001:2008 Clause 5.6.
8.2 Responsibilities
The General Manager of the Project Design Office:
Establishes the frequency of the Management Review (nominally annually);
Determines the scope of review;
Reviews the QMS and identifies action parties, reviews action responses, agrees action closeout.
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All personnel in the Design Office should keep the QA Team informed of any actions that may require inclusion in the
Action Tracker. Observations will be recorded on a separate tracker.
The spreadsheet will be maintained as a live document in the QA section of the shared network drive, and will include
the following information relating to each action, where applicable:
Source of Action
Reference number (e.g. Audit Number, and where there is more than one action add 01a, 02a etc on the end)
Date of Action / Finding
Type (NCR/ Preventive Action / Opportunity for Improvement)
Severity of NCR
Finding Description/Detailed Action
Action – Short Description
Target Date for Completion of Action
Action Party
Status – Open/ Closed/ Withdrawn
Actual Completion Date
Verified By
Comments (including status of action etc)
Note that all actions should result from a corresponding finding, and that a single finding may result in more than one
action.
A summary of the action status will be reported by the QA Team to the Design Office Leadership Team as part of the
Monthly Report.
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10 Abbreviations
11 Definitions
Corrective Action: action to eliminate the cause of detected non-conformity or other undesirable situation, and
prevent recurrence.
Deliverable: The output from an activity and/or process in the form of data, document, or drawing that is generated as
a part of a service or product.
Document: Record, specification, procedure, drawing, report and standards. Information and its supporting medium.
Improvement Proposal (=Preventive Action): something uncovered at the time of an audit, which may not be non-
conforming, but may have the potential for improvement in the opinion of an auditor.
LiveLink (LL): Shell web-based environment and repository for the storage of electronic information, hyperlink
attached here:
Non-Conformity: non-fulfilment of a requirement.
Originator: the person who originates an engineering design document, deliverable or drawing.
Preventive Action: action to eliminate the cause of a potential non-conformity or other undesirable potential situation.
Preventive action is taken to prevent occurrence whereas corrective action is taken to prevent recurrence.
PTM-EDES-PR-16 -
F01 Non-Conformity Form.docx
PTM-EDES-PR-16-F0
2 - Improvement Proposal - Preventive Action Form.docx
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Quality Improvement Revision: 01R
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